Robotic catheter rotatable device cartridge

ABSTRACT

A robotic catheter rotatable device cartridge may include a housing member attachable to a drive mechanism for rotating the cartridge and a catheter attached to the cartridge along an axial direction of the catheter. A slider block may be generally slidable relative to the housing and engaged with one or more steering wires for controlling movement of the catheter in a transverse direction relative to the axial direction. The catheter may include the steering wire(s) engaged therewith and movable in the transverse direction when the slider block is linearly driven in a predetermined direction.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.12/347,842, filed 31 Dec. 2008 (the '842 application), now pending,which claims the benefit of priority to U.S. Provisional ApplicationNos. 61/040,143, filed Mar. 27, 2008 (the '143 application) and61/099,904, filed Sep. 24, 2008 (the '904 application). The '842application, the '143 application and the '904 application are herebyincorporated by reference in their entirety as though fully set forthherein.

BACKGROUND OF THE INVENTION

a. Field of the Invention

This invention relates to a robotic catheter system and method forautomated control of a catheter and related components. In particular,the instant invention relates to a removable robotic rotatable devicecartridge usable with a robotic catheter system for manipulating acatheter and related components, for example, for diagnostic,therapeutic, mapping and ablative procedures.

b. Background Art

Electrophysiology catheters are used in a variety of diagnostic and/ortherapeutic medical procedures to correct conditions such as atrialarrhythmia, including for example, ectopic atrial tachycardia, atrialfibrillation, and atrial flutter. Arrhythmia can create a variety ofdangerous conditions including irregular heart rates, loss ofsynchronous atrioventricular contractions and stasis of blood flow whichcan lead to a variety of ailments and even death.

Typically in a procedure, a catheter is manipulated through a patient'svasculature to, for example, a patient's heart, and carries one or moreelectrodes which may be used for mapping, ablation, diagnosis, or othertreatments. Once at the intended site, treatment may include radiofrequency (RF) ablation, cryoablation, lasers, chemicals, high-intensityfocused ultrasound, etc. An ablation catheter imparts such ablativeenergy to cardiac tissue to create a lesion in the cardiac tissue. Thislesion disrupts undesirable electrical pathways and thereby limits orprevents stray electrical signals that lead to arrhythmias. As readilyapparent, such treatment requires precise control of the catheter duringmanipulation to and at the treatment site, which can invariably be afunction of a user's skill level.

The inventors herein have thus recognized a need for a system and methodfor precise and dynamic automated control of a catheter and its relatedcomponents, for example, for diagnostic, therapeutic, mapping andablative procedures, that will minimize and/or eliminate proceduralvariability due to a user's skill level. The inventors herein have alsorecognized a need for a system and method for performing user-specifiedprocedures at the patient site or from a remote location.

BRIEF SUMMARY OF THE INVENTION

It is desirable to provide a system and method for precise and dynamicautomated control of a catheter and its related components. Inparticular, it is desirable to provide a system and method for preciseand dynamic automated control, for example, for diagnostic, therapeutic,mapping and ablative procedures, that will minimize and/or eliminateprocedural variability due to a user's skill level, with the proceduresbeing optionally performed at the patient site or from a remotelocation.

A system and method for precise and dynamic automated control of acatheter and its related components may include a robotic catheterrotatable device cartridge that eliminates backlash, “slop” and otherdiscontinuities in catheter and sheath control that can make computercontrol thereof difficult. The system and method, as discussed herein,may generally include a linear mechanism between the drive means andcatheter tip, as opposed to a rotary system which operates on the radiuschange of a wire for controlling a catheter tip, thus significantlyenhancing the overall control function.

A system and method for precise and dynamic automated control of acatheter and its related components may include a robotic catheterrotatable device cartridge including a housing member attachable to adrive mechanism for rotating the cartridge and a catheter attached tothe cartridge along an axial direction of the catheter. One or moreslider blocks may be generally slidable relative to the housing andengaged with one or more steering wires for controlling movement of thecatheter in a transverse direction relative to the axial direction. Thecatheter may include the steering wire engaged therewith and movable inthe transverse direction when the slider block is linearly driven in apredetermined direction.

For the robotic catheter rotatable device cartridge described above, inone embodiment, the housing may be removably attachable to a drive headfor rotatable attachment to the drive mechanism, and the slider blockmay be engageable with a drive head mount for linear driving of theslider block. In one embodiment, a magnetic mount may be provided in thehousing or the drive head for engagement with a complementary surface onthe other one of the housing or the drive head for releasable locking ofthe cartridge with the drive head. In one embodiment, one or morerecesses may be provided in the housing or the drive head for engagementwith one or more complementary locking detents on the other one of thehousing or the drive head for releasable locking of the cartridge withthe drive head.

For the robotic catheter rotatable device cartridge described above, inone embodiment, two steering wires may be provided for controllingmovement of the catheter in generally opposing transverse directions. Inone embodiment, the slider block may be linearly driveable to pull thesteering wire generally linearly along a length of the steering wire.

A system and method for precise and dynamic automated control of acatheter and its related components may include a robotic catheterrotatable device cartridge including a housing member attachable to adrive mechanism for rotating the cartridge and a surgically insertabledevice attached to the cartridge generally along an axial direction ofthe surgically insertable device. One or more first elements may begenerally linearly movable along the housing and engaged with one ormore steering wires for controlling movement of the surgicallyinsertable device in a transverse direction relative to the axialdirection. The surgically insertable device may include the steeringwire engaged therewith and be movable in the transverse direction whenthe first element is linearly driven in a predetermined direction.

For the robotic catheter rotatable device cartridge described above, inone embodiment, the housing may be removably attachable to a drive headfor rotatable attachment to the drive mechanism, and the first elementmay be engageable with a second element on the drive head for lineardriving of the first element. In one embodiment, the robotic catheterrotatable device cartridge may include one or more first engageablemembers on the housing or the drive head for engagement with one or morecomplementary engageable member on the other one of the housing or thedrive head for releasable locking of the cartridge with the drive head.In one embodiment, one or more magnetic mounts may be provided in thehousing or the drive head for engagement with a complementary surface onthe other one of the housing or the drive head for releasable locking ofthe cartridge with the drive head.

For the robotic catheter rotatable device cartridge described above, inone embodiment, two steering wires may be provided for controllingmovement of the surgically insertable device in generally opposingtransverse directions. In one embodiment, the first element may belinearly driveable to pull the steering wire generally linearly along alength of the steering wire. In one embodiment, the first element may bea slider block linearly slidable along a channel on or in the housing.In one embodiment, the surgically insertable device may be a catheter, asheath or a transseptal needle. The linear moveability of the firstelement, in one embodiment, may generally eliminate any backlash ordiscontinuities during driving of the surgically insertable device. Inone embodiment, the cartridge may be infinitely rotatable. In oneembodiment, the robotic catheter rotatable device cartridge may includeintegrated force sensors operatively connected to the cartridge forpermitting active tensioning of the steering wire for controllingmovement of the surgically insertable device. The robotic catheterrotatable device cartridge, in one embodiment, may include integratedforce sensors operatively connected to the cartridge for limiting stresson the surgically insertable device by limiting movement of thecartridge.

The foregoing and other aspects, features, details, utilities andadvantages of the present invention will be apparent from reading thefollowing description and claims, and from reviewing the accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an isometric diagrammatic view of a robotic catheter system,illustrating an exemplary layout of various system components;

FIG. 2 is an isometric diagrammatic view of a first embodiment of arobotic catheter manipulator support structure, illustrating a roboticcatheter manipulator slightly angled from a generally horizontalposition;

FIGS. 3 a-3 c are enlarged isometric, and FIGS. 3 d-3 i are respectivelyenlarged left side, right side, top, front, back and a correspondingleft side view of a first embodiment of a robotic catheter manipulatorassembly, and FIGS. 3 j-3 m are respectively enlarged left side, rightside, top and front views of the robotic catheter manipulator assemblyof FIG. 3 a, illustrating use of the manipulator assembly with a roboticcatheter rotatable device cartridge;

FIGS. 4 a-4 c are enlarged isometric views, and FIGS. 4 d-4 g arerespectively enlarged top and right side, and respectively sections A-Aand B-B taken generally along lines A-A and B-B in FIG. 4 d, of a firstembodiment of a manipulation base;

FIGS. 5 a-5 e are enlarged isometric views of a first embodiment of arobotic catheter device cartridge, with FIG. 3 a illustrating anexemplary usage of the robotic catheter device cartridge;

FIGS. 6 a-6 c are enlarged isometric, FIGS. 6 d and 6 e are left sideand right side, and FIG. 6 f is section A-A taken generally along lineA-A in FIG. 6 d, views of a robotic catheter rotatable drive mechanism,with FIGS. 3 j-3 m illustrating an exemplary usage of the roboticcatheter rotatable drive mechanism;

FIGS. 7 a and 7 b are enlarged isometric, FIGS. 7 c-7 e are top, frontand side, FIG. 7 f is section A-A taken generally along line A-A in FIG.7 d, FIG. 7 g is an enlarged area of FIG. 7 f, and FIGS. 7 h-7 n aredrive layout views of a robotic catheter rotatable drive head, withFIGS. 3 j-3 m illustrating an exemplary usage of the robotic catheterrotatable drive head;

FIGS. 8 a-8 c are enlarged isometric, front and side, and FIG. 8 d issection A-A taken generally along line A-A in FIG. 8 b, views of arobotic catheter rotatable device cartridge, with FIGS. 3 j-3 millustrating an exemplary usage of the robotic catheter rotatable devicecartridge;

FIGS. 9 a and 9 b are enlarged isometric views of a second embodiment ofa robotic catheter manipulation base and robotic catheter devicecartridge;

FIGS. 10 a and 10 b are enlarged isometric and bottom views of a thirdembodiment of a robotic catheter manipulation base and robotic catheterdevice cartridge; and

FIGS. 11 a and 11 b are enlarged isometric views of a fourth embodimentof a robotic catheter manipulation base and robotic catheter devicecartridge.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

Referring now to the drawings wherein like reference numerals are usedto identify identical components in the various views, an embodiment ofrobotic catheter system 10 (described in detail in commonly owned andcopending application titled “Robotic Catheter System”), also referredto as “the system,” may be likened to power steering for a cathetersystem. The system may be used, for example, to manipulate the locationand orientation of catheters and sheaths in a heart chamber or inanother body cavity. As shown in FIG. 1 and described in detail below,robotic catheter system 10 may generally incorporate a human inputdevice and control system (referred to as “input control system”) 100,e.g., a joystick and related controls (described in detail in commonlyowned and copending applications titled “Robotic Catheter System InputDevice” and “Robotic Catheter System Including Haptic Feedback”), that auser such as an electrophysiologist (EP) may interact with, anelectronic control system 200 (described in detail in commonly owned andcopending application titled “Robotic Catheter System with DynamicResponse”) that translates motions of the user at the input device intoa resulting movement of a catheter tip, and a visualization system 12that provides a user with real-time or near-real-time positioninginformation concerning the catheter tip. The system may further includeclosed-loop feedback using an EnSite NavX system 14 and/or optical forcetransducers, a robotic catheter manipulator assembly 300 (described indetail in commonly owned and copending application titled “RoboticCatheter Manipulator Assembly”) for operating a robotic catheter devicecartridge 400 (described in detail below and in commonly owned andcopending application titled “Robotic Catheter Device Cartridge”), andmanipulator support structure 150 (described in detail in commonly ownedand copending application titled “Robotic Catheter System”). The systemprovides the user with a similar type of control provided by aconventional manual system, but allows for repeatable, precise, anddynamic movements. The respective disclosures of the above-identifiedand other commonly owned and copending applications discussed in thisapplication are incorporated herein by reference.

An embodiment of robotic catheter system 10 may involve automatedcatheter movement. A user, such as an EP, could identify locations(potentially forming a path) on a rendered computer model of the cardiacanatomy. The system can be configured to relate those digitally selectedpoints to positions within a patient's actual/physical anatomy, and maycommand and control the movement of a catheter to defined positions.Once in position, either the user or system could then perform thedesired treatment or therapy—which may further be in accordance with adefined algorithm. This system could enable full robotic control byusing optimized path planning routines together with closed-loopposition control. Furthermore, the system could automate certain“best-practices,” such as pulling the catheter across the surface, ormaking contact at an oblique angle.

Referring to FIG. 1, input control system 100 will be described briefly.

Input control system 100 of commonly owned and copending applicationtitled “Robotic Catheter System Input Device,” may generally allow auser to control the movement and advancement of both the catheter andsheath. Generally, several types of joysticks may be employed,including, without limitation, instrumented traditional catheter handlecontrols, oversized catheter models, instrumented, user-wearable gloves,and traditional joysticks. In embodiments, for example and withoutlimitation, the joystick may be spring centering so that any movementfrom the center position causes an incremental movement of the actualcatheter tip, or the joystick may work in absolute terms. Hapticfeedback may also be incorporated to provide a user with a sense of whencontact has been made.

Referring to FIG. 1, electronic control system 200 will be describedbriefly.

As discussed in detail in commonly owned and copending applicationstitled “Robotic Catheter System Input Device,” and “Robotic CatheterSystem with Dynamic Response,” many additional features may be includedwith embodiments of the system to, for example, improve the accuracy oreffectiveness of the system. Such features may include, closed-loopfeedback using EnSite NavX system 14 for creating realistic cardiacchamber geometries or models, displaying activation timing and voltagedata to identify arrhythmias, and guiding precise catheter movement,and/or optical force transducers; active tensioning of “passive”steering wires to reduce the system response time; cumulative ablationwhile the tip is following a front-to-back ironing motion; and/orreactive/resistive impedance monitoring.

Referring to FIG. 1, visualization system 12 will be described briefly.

Visualization system 12 may provide a user with real-time ornear-real-time positioning information concerning the catheter tip. Inan exemplary embodiment, system 12 may include an EnSite NavX monitor 16for displaying cardiac chamber geometries or models, displayingactivation timing and voltage data to identify arrhythmias, and forfacilitating guidance of catheter movement. A fluoroscopy monitor 18 maybe provided for displaying a real-time x-ray image or for assisting aphysician with catheter movement. Additional exemplary displays mayinclude an ICE and EP Pruka displays, 20, 22, respectively.

Referring to FIG. 1, EnSite NavX system 14 will be described briefly.

EnSite NavX system 14 (described in detail in U.S. Pat. No. 7,263,397,titled “Method and Apparatus for Catheter Navigation and Location andMapping in the Heart,” incorporated by reference in its entirety) may beprovided for creating realistic cardiac chamber geometries or models,displaying activation timing and voltage data to identify arrhythmias,and guiding precise catheter movement. EnSite NavX system 14 may collectelectrical data from catheters and use this information to track ornavigate their movement and construct three-dimensional (3-D) models ofthe chamber.

Referring to FIGS. 1 and 3 a-5 e, the catheter and sheath configurationof robotic catheter manipulator assembly 300 and robotic catheter devicecartridges 400 will be described in detail for facilitating anunderstanding of robotic catheter system 10, and robotic catheterrotatable device cartridge 700 and its related components.

As generally shown in FIGS. 1 and 3 a-5 e, robotic catheter system 10may include one or more robotic catheter manipulator assemblies 300 thatserve as the mechanical control for the movements or actions of one ormore robotic catheter device cartridges 400. FIG. 1 illustrates agenerally vertically oriented manipulator assembly 300 for minimizingapproach angle, and FIG. 2 illustrates a manipulator assembly 380slightly angled from a generally horizontal position. A first embodimentof manipulator assembly 302 may respectively include both catheter andsheath manipulator mechanisms 304, 306. In this arrangement, thecatheter and sheath manipulator mechanisms 304, 306 may be aligned suchthat the catheter can pass through the sheath in a coaxial arrangement.Each mechanism 304, 306 may be further capable of independentadvancement/retraction (shown generally as directions D₁ and D₂) andindependent four-wire steering control (e.g., eight total steeringwires, comprising four sheath control wires and four catheter controlwires), as discussed in detail below.

With a configuration of robotic catheter system 10, such as shown inFIGS. 1 and 3 a-5 e, there will be relative travel of a first embodimentof catheter and sheath cartridges 402, 404 and relative movementassociated with a portion of a catheter 406 between the two cartridges402, 404. For many embodiments, there may be a water-tight fit of aproximal sheath opening 408, which can sometimes create resistance tocatheter advancement. In order to help eliminate/reduce the potentialissue of columnar buckling of catheter 406, a length of stiff material,such as, for example, a solid metal rod or fiber reinforced composite,may be incorporated on the interior of the proximal portion of catheter406. Such a material may locally increase the catheter's bendingstiffness and provide enhanced buckling support. Thus catheter 406 maybe proximally stiffened so that the length of the catheter proximallyextending from sheath cartridge 404 is less likely to buckle duringrelative translation, as the entire length of catheter 406 extends intosheath 410.

Referring to FIGS. 1 and 3 a-5 e, the first embodiment of roboticcatheter manipulator assembly 302 will be described in detail.

As generally shown in FIGS. 1 and 3 a-5 e, robotic catheter system 10which includes one or more robotic catheter manipulator assemblies 300,includes the first embodiment of robotic catheter manipulator assembly302 including both catheter and sheath manipulation mechanisms 304, 306for manipulating, for example, catheter and sheath cartridges 402, 404.Manipulator assembly 302 may include interconnected/interlockingmanipulation bases 308, 310 for catheter and sheath cartridges 402, 404,and likewise may include electrical “handshake” functionality asdiscussed below. Each interlocking base 308, 310 may be capable oftravel in the longitudinal direction of the catheter/sheath (D₁, D₂respectively). In an embodiment, D₁ and D₂ may each represent atranslation of approximately 8 linear inches. As shown in FIG. 3 a, eachinterlocking base may be translated by high precision drive mechanisms312, 314. Such drive mechanisms may include, for example and withoutlimitation, a motor driven lead screw or ball screw.

As shown in FIGS. 3 a-3 i and 4 a-4 g, for each cartridge 402, 404, anassociated manipulation base 308, 310 may include a plurality of fingers316, 318, 320 and 322, (e.g., one per steering wire) that extend orprotrude upwardly to contact and interact with the steering wire sliderblocks (such as slider blocks 412, 414, 416, 418) to independentlytension select steering wires 420, 422, 424, 426. Each finger can beconfigured to be independently actuated by a precision drive mechanism,such as a motor driven ball screw 324, and may be outfitted with forcesensors to measure corresponding steering wire tension. Each motordriven ball screw (for both finger control and cartridge translationcontrol) may further include encoders to measure a relative and/or anabsolute position of each element of the system. As shown in FIG. 4 a,bearing 332 and coupler 330 of ball screw 324 may engage frame 340 ofrespective bases 308, 310 and a corresponding finger 316, 318, 320 or322 may be mounted adjacent a strain gauge for measuring thecorresponding steering wire tension.

Referring to FIGS. 4 a-4 g, bases 308, 310 may include exemplarycomponents such as motors 342, 344, 346 and 348, respectively coupled tofingers 316, 318, 320 and 322. A bearing 354 may be provided for slidingof bases 308, 310 on track 356. A plurality of inductive sensors (e.g.home sensors) 358 may be provided for guiding each manipulation base toa safe position.

Manipulator assembly 302 may be disposed in a vertical configuration(see FIG. 1) for minimizing both the approach angle of the catheter andthe distance the catheter must extend from the patient, or slightlyangled from a generally horizontal position (see FIG. 2). In thevertical configuration of FIG. 1, the approach angle and catheterextension distance may be minimized by vertically orienting thebackplane of the manipulator head, with the interlocking cartridgespositioned at the lower extreme such that they may travel nearlyhorizontally and substantially in line with the point of entry into thepatient (e.g., as generally illustrated in FIG. 1). In such anembodiment, with the backplane of the manipulator head verticallyoriented, the positioning of the manipulator head structure may allowthe proximal control of the catheter/sheath to be held closely to thepatient's body without substantial structural interference. In anembodiment, high-precision drive mechanisms 312, 314 for translatingeach of the catheter and sheath cartridges 402, 404 may be positionedgenerally below the manipulator bases 308, 310 to allow the respectivecartridges to be positioned toward the lower area of the manipulator. Byholding a close distance, the ingress angle of the catheter/sheath maybe minimized, and the manipulator control may be positioned more closelyto an insertion site.

Referring to FIGS. 1-3 m, particularly FIGS. 3 j-3 m, robotic cathetermanipulator assembly 302 may be usable with a robotic catheter rotatabledevice cartridge 700, described in detail below. As shown in FIG. 3 m,manipulator base 308 may be replaced with a robotic catheter rotatabledrive mechanism 500, described briefly herein and in detail in commonlyowned and copending application titled “Robotic Catheter Rotatable DriveMechanism,” and a robotic catheter rotatable drive head 600.

Referring to FIGS. 1 and 5 a-5 e, catheter and sheath cartridges 402,404 will be described in detail.

As briefly discussed above, robotic catheter system 10 may include oneor more cartridges 400, with manipulator 302 including at least twocartridges 402, 404, each of which may be respectively designed tocontrol the distal movement of either the catheter or the sheath. Withrespect to catheter cartridge 402, catheter 406 may be substantiallyconnected or affixed to cartridge 402, so that advancement of cartridge402 correspondingly advances catheter 406, and retraction of thecartridge retracts the catheter. As further shown in FIGS. 5 a-5 e anddiscussed above, in an embodiment, each cartridge 402, 404 may includeslider blocks (e.g., 412, 414, 416, 418), each rigidly (andindependently) connected or affixed to one of a plurality of cathetersteering wires (e.g., 420, 422, 424, 426) in a manner that permitsindependent tensioning of each steering wire. The cartridge may beprovided as a disposable item that is capable of being easily positioned(e.g., snapped) into place in an overall assembly. In an embodiment, asdiscussed in detail below, the cartridge may include an electrical“handshake” device or component to allow the system to properly identifythe cartridge (e.g., by type and/or proper placement/positioning).Sheath cartridge 404 may be designed in a similar manner as the cathetercartridge 402, but will typically be configured to provide for thepassage of catheter 406. Assembly 302 may include a plurality (e.g., asmany as ten or more) of independent driving mechanisms (e.g. motordriven ball screws 324).

For some embodiments, the catheter and sheath cartridge can be designedto be substantially similar, and in that context a reference to eithermay relate to both. For example, as shown in FIGS. 5 a-5 e, the designof the catheter/sheath cartridge may include upper and lower cartridgesections 428, 430, and independent slider blocks 412, 414, 416, 418. Thesystem is not generally limited to specific material selection orformation techniques. However, in an embodiment, the upper and lowercartridge sections 428, 430 may be injection molded using apolycarbonate material. Each slider block 412, 414, 416, 418 may beconnected to a separate catheter steering wire 420, 422, 424, 426, andmay be formed of a Teflon-like material such as, for example, Delrin AF.When in contact with the cartridge housing portions 428, 430, suchTeflon-like slider blocks may maintain a low static and dynamiccoefficient of friction and may avoid the need for additionallubrication.

Referring to FIGS. 3 a-5 e and as discussed above, catheter and sheathcartridges 402, 404 may be configured to secure or lock down ontorespective interconnecting catheter and sheath manipulation bases 308,310. To couple cartridge 402 (and 404) with base 308 (and 310), one ormore locking pins (e.g., 432 in FIGS. 5 a, 5 d and 5 e) on the cartridgemay engage one or more mating recesses 360 in the base (see FIG. 4 a).In an embodiment, such recesses 360 may include an interference locksuch as a spring detent or other locking means. In an embodiment, suchother locking means may include a physical interference that may requireaffirmative/positive action by the user to release the cartridge. Suchaction may include or require actuation of a release lever 362.Additionally, as shown in FIGS. 5 c, 5 d and 5 e, cartridge 402 (and404) may include one or more locator pins 434 that are configured topassively fit into mating holes on the base (e.g., 364 in FIG. 4 a).

In an embodiment, a user (e.g. an EP) may first manually positioncatheter 406 and sheath 410 (with catheter 406 inserted in sheath 410)within the vasculature of a patient. Once the devices are roughlypositioned in relation to the heart, the user may then engage or connect(e.g., “snap-in”) the catheter cartridge into place oninterconnecting/interlocking bases 308, 310 of manipulator assembly 302,for example, by inserting the locking/locating pins 432, 434 of thecartridges into mating holes 360, 364 of respective base 308, 310. Whenthe cartridge is interconnected with the base, each of the plurality offingers 316, 318, 320 or 322 may fit into recesses formed between thedistal edge of slider blocks 412, 414, 416, 418 and a lower portion ofthe cartridge housing. Such recesses are shown in, for example, FIGS. 5d and 5 e.

Each finger may be designed to be actuated in a proximal direction tocorrespondingly push each respective slider block. The slider block canbe configured to force the finger to self center on its geometry whencontact is first made. Such a centering feature may be facilitated bythe contact surface of the slider block. For example, as shown in FIGS.5 d and 5 e, the slider block may include an engagement surface (e.g.,shaped as a semi-cylindrical recess in the forward facing portion). Thissurface may be configured to mate or communicate with a matching roundportion of a corresponding finger.

With sufficiently rigid coupling between each slider block and acorresponding steering wire, pushing a slider block in a proximaldirection may cause an attached steering wire to tension and thuslaterally deflect the distal end of the catheter and sheath 406, 410.Moreover, in such an embodiment, because there is no rigid connectionbetween each finger and its associated slider block, the manipulatorassembly 302 cannot pull the steering wire in a forward direction. Thatis, when each block is actuated, it is only possible to tension thesteering wire. Furthermore, because the push-actuation of each sliderblock occurs near that block's bottom surface, a moment may be imposedon the block. Because such a moment may increase the likelihood of theblock binding during travel, the length of the block may be optimized toreduce or minimize contact forces between the block and the cartridgehousing.

Referring to FIGS. 1-8 d, particularly FIGS. 6 a-8 d, robotic catheterrotatable device cartridge 700 usable with robotic catheter manipulatorassembly 302 will be described in detail in conjunction with roboticcatheter rotatable drive mechanism 500 (described in detail in commonlyowned and copending application titled “Robotic Catheter Rotatable DriveMechanism.”) and robotic catheter rotatable drive head 600.

As briefly discussed above, robotic catheter system 10 may include oneor more cartridges 400, with manipulator 302 including at least twocartridges 402, 404, each of which may be respectively designed tocontrol the distal movement of either the catheter or the sheath. Asshown in FIGS. 3 a and 6 a-8 d, catheter manipulation base 308 andcatheter cartridge 402 may be respectively replaced with roboticcatheter rotatable drive mechanism 500 and robotic catheter rotatabledrive head 600, and robotic catheter rotatable device cartridge 700.

Referring to FIGS. 6 a-6 f, mechanism 500 may generally include a motorand belt drive assembly 502 for rotatably driving robotic catheterrotatable drive head 600 including cartridge 700 releasably mountedthereon. Assembly 502 may include motors 504, 506, 508 for respectivelydriving belts 510, 512, 514. While belt 510 may rotatably drive theshaft of drive head mount 516 via pulley/gear 518 to rotatably driverobotic catheter rotatable drive head 600, belts 512, 514 may drivepulleys/gears 520, 522 to move right and left wire sliders 602, 604 ofdrive head 600 along the axis of cartridge 700 (see also FIGS. 7 h-7 n,which illustrate the respective drive configuration for pulleys/gears518, 520 and 522). As shown in FIG. 6 d, a bearing 524 may be providedfor slidable positioning of mechanism 500 on track 356 of manipulator302.

Referring to FIGS. 7 a-7 n, robotic catheter rotatable drive head 600may generally include sliders 602, 604 as discussed above respectivelymounted to rods 606, 608, and driven by lead screws 610, 612. Leadscrews 610, 612 may be respectively driven by pulleys/gears 520, 522,and drive head 600 may include detents 614, 616 for driving engagementwith slider blocks 708, 710 of cartridge 700. A pair of hooks 618, 620may also be provided for retention of cartridge 700.

Referring to FIGS. 7 a-8 d, cartridge 700 may include catheter 706substantially connected or affixed thereto, so that advancement orrotation of cartridge 700 correspondingly advances or rotates catheter706, and retraction of the cartridge retracts the catheter. Sliderblocks 708, 710 may each be rigidly (and independently) connected oraffixed to one of a plurality of catheter steering wires 712, 714 in amanner that permits independent tensioning of each steering wire.Steering wires 712, 714 may be connected to the slider blocks by meansof set screws 716 or other means known in the art. A pair of magneticmounts 718 may be provided for complementary engagement with drive head600. Further, slider blocks 708, 710 may include concave indents 720,722 for complementary engagement with detents 614, 616 of drive head600. Hooks 618, 620 of drive head 600 may also engage with slider blocks708, 710 as shown in FIG. 7 d. The cartridge may be provided as adisposable item that is capable of being easily positioned (e.g.,snapped) into place in an overall assembly. In an embodiment, asdiscussed in detail below, the cartridge may include an electrical“handshake” device or component to allow the system to properly identifythe cartridge (e.g., by type and/or proper placement/positioning).Assembly 302 may include a plurality (e.g., as many as ten or more) ofindependent driving mechanisms (e.g. motor driven ball screws 324).

As shown in FIGS. 8 a-8 d, the design of cartridge 700 may include upperand lower cartridge sections 724, 726, and independent slider blocks708, 710. The system is not generally limited to specific materialselection or formation techniques. However, in an embodiment, the upperand lower cartridge sections 724, 726 may be injection molded using apolycarbonate material. Each slider block 708, 710 may be connected to aseparate catheter steering wire 712, 714, and may be formed of aTeflon-like material such as, for example, Delrin AF. When in contactwith the cartridge housing portions 724, 726, such Teflon-like sliderblocks may maintain a low static and dynamic coefficient of friction andmay thus avoid the need for additional lubrication.

Referring to FIGS. 1-8 d and as discussed above, catheter and sheathcartridges 700, 404 may be configured to secure or lock down ontorespective interconnecting catheter drive mechanism 500 and drive head600, and sheath manipulation base 310. In an embodiment, a user (e.g. anEP) may first manually position catheter 706 and sheath 410 (withcatheter 706 inserted in sheath 410) within the vasculature of apatient. Once the devices are roughly positioned in relation to theheart, the user may then engage or connect (e.g., “snap-in”) thecatheter and sheath cartridges into place on drive mechanism 500 anddrive head 600, and sheath manipulation base 310 of manipulator assembly302, for example. When the cartridges are interconnected with the base,for sheath cartridge 404 each of the plurality of fingers 316, 318, 320or 322 may fit into recesses formed between the distal edge of sliderblocks 412, 414, 416, 418 and a lower portion of the cartridge housing.For catheter cartridge 700, detents 614, 616 may engage slider blocks708, 710 as discussed above.

Each finger/detent may be designed to be actuated in a proximaldirection to correspondingly push each respective slider block. Theslider block can be configured to force the finger to self center on itsgeometry when contact is first made. Such a centering feature may befacilitated by the contact surface of the slider block.

With sufficiently rigid coupling between each slider block and acorresponding steering wire, pushing a slider block in a proximaldirection may cause an attached steering wire to tension and thuslaterally deflect the distal end of the catheter and sheath 706, 410.For rotation of catheter 706, cartridge 700 may be rotated as needed bypulley/gear 518. Since cartridge 700 is also allowed to spin infinitely,this further amplifies the maneuverability of catheter 706. Moreover, insuch an embodiment, because there is no rigid connection between eachfinger/detent and its associated slider block, the manipulator assembly302 or drive mechanism 500 and drive head 600 cannot pull the steeringwire in a forward direction. That is, when each block is actuated, it isonly possible to tension the steering wire.

Referring to FIGS. 9 a-11 b, embodiments of manipulation bases andcartridges described in detail in commonly owned and copendingapplications titled “Robotic Catheter Manipulator Assembly” and “RoboticCatheter Device Cartridge” are illustrated.

Referring to FIGS. 9 a and 9 b, a manipulation base 800 includesprotruding and linearly movable fingers 802, 804, 806, 808 for operatingcartridge 810 including pins 812, 814 (opposite of pin 816), 816 and818. It is conceivable that for the design of mechanism 500 andcartridge drive head 600 discussed above, slider blocks 708, 710 ofcartridge 700 may be linearly movable by a mechanism similar tomanipulation base 800.

Referring to FIGS. 10 a and 10 b, a manipulation base 820 includesprotruding and linearly movable fingers 822, 824, 826, 828 for operatingcartridge 830 including slider blocks 832, 834, 836 and 838. It isconceivable that for the design of mechanism 500 and cartridge drivehead 600 discussed above, slider blocks 708, 710 of cartridge 700 may belinearly movable by a mechanism similar to manipulation base 820.

Referring to FIGS. 11 a and 11 b, a manipulation base 840 includeslinearly movable slider blocks 842, 844, 846, 848 for operatingcartridge 850 including protruding fingers 852, 854, 856 and 858. It isconceivable that for the design of mechanism 500 and cartridge drivehead 600 discussed above, slider blocks 708, 710 of cartridge 700 may belinearly movable by a mechanism similar to manipulation base 840.

The aforementioned electrical handshake between manipulation bases 308,310 and catheter and sheath cartridges 402, 404, as well as mechanism500, drive head 600 and cartridge 700 will be described briefly.

Robotic catheter system 10 may be useful for a variety of procedures andin connection with a variety of tools and/or catheters. Such toolsand/or catheters may include, without limitation, spiral catheters,ablation catheters, mapping catheters, balloon catheters, needle/dilatortools, cutting tools, cauterizing tools, and/or gripping tools. Thesystem may additionally include a means of identifying the nature and/ortype of catheter/tool cartridge that is installed for use, and/orposition or connection related information. The system may automaticallyaccess/obtain additional information about the cartridge, such as,without limitation, its creation date, serial number, sterilizationdate, prior uses, etc.

Further, some embodiments of the system may include an ability to “read”or detect the type or nature of the connected cartridge through the useof memory included with the disposable cartridge together with somedata/signal transmission means. By way of example, each cartridge maycontain a chip (e.g., an EEPROM chip) that can be electricallyinterfaced by the manipulator head. Such a chip could, for instance, beprogrammed during the manufacturing process and may electronically storevarious data, such as the make; model; serial number; creation date;and/or other special features associated with the cartridge or tool.Additionally the chip may contain other worthwhile information, such asan indication of previous use, catheter specific calibration data,and/or any other information that may relate to the safety orperformance of the particular device.

Although several embodiments of this invention have been described abovewith a certain degree of particularity, those skilled in the art couldmake numerous alterations to the disclosed embodiments without departingfrom the scope of this invention. All directional references (e.g.,upper, lower, upward, downward, left, right, leftward, rightward, top,bottom, above, below, vertical, horizontal, clockwise andcounterclockwise) are only used for identification purposes to aid thereader's understanding of the present invention, and do not createlimitations, particularly as to the position, orientation, or use of theinvention. Joinder references (e.g., attached, coupled, connected, andthe like) are to be construed broadly and may include intermediatemembers between a connection of elements and relative movement betweenelements. As such, joinder references do not necessarily infer that twoelements are directly connected and in fixed relation to each other. Itis intended that all matter contained in the above description or shownin the accompanying drawings shall be interpreted as illustrative onlyand not as limiting. Changes in detail or structure may be made withoutdeparting from the invention as defined in the appended claims.

What is claimed is:
 1. A robotic catheter device cartridge comprising: ahousing member removably attachable to a drive mechanism for rotatingthe cartridge and a surgically insertable device attached to thecartridge generally along an axial direction of the surgicallyinsertable device; at least one slider block generally linearly slidablealong a channel associated with the housing and engaged with at leastone steering wire for controlling movement of the surgically insertabledevice in a transverse direction relative to the axial direction, thesurgically insertable device having the steering wire engaged therewithand being movable in the transverse direction when the slider block islinearly driven in a predetermined direction to pull the steering wiregenerally linearly along a length of the steering wire; and one or moreintegrated force sensors operatively connected to the cartridge tofacilitate active tensioning of the steering wire for controllingmovement of the surgically insertable device.
 2. The robotic catheterdevice cartridge according to claim 1, wherein the housing is removablyattachable to a drive head for rotatable attachment to the drivemechanism, and further comprising: at least one first engageable memberon one of the housing and the drive head for engagement with at leastone complementary engageable member on the other one of the housing andthe drive head for releasable locking of the cartridge with the drivehead; and at least one magnetic mount in one of the housing and thedrive head for engagement with a complementary surface on the other oneof the housing and the drive head for releasable locking of thecartridge with the drive head.
 3. The robotic catheter device cartridgeaccording to claim 1, further comprising two steering wires forcontrolling movement of the surgically insertable device in generallyopposing transverse directions.
 4. The robotic catheter device cartridgeaccording to claim 1, wherein: the surgically insertable device is oneof a catheter, a sheath and a transseptal needle; the linear moveabilityof the slider block reduces backlash or discontinuities during drivingof the surgically insertable device; and the cartridge is infinitelyrotatable.